Dr João Pedro R. Feitosa (pictured), a 28-year-old from Rio De Janeiro, Brazil, was confirmed to be the volunteer who died in the Brazilian arm of AstraZeneca and the University of Oxford’s coronavirus vaccine trial
A volunteer in the Brazilian arm of AstraZeneca and the University of Oxford’s coronavirus vaccine trial has died, the country’s health authority Anvisa said on Wednesday.
G1 Rio in Brazil has confirmed the participant to be Dr João Pedro R. Feitosa, a 28-year-old from Rio De Janeiro.
He is reported to have died from complications from COVID-19, the disease caused by the virus, on Thursday, October 15.
Reports indicate that Feitosa was not in the group that received the vaccine with sources telling Reuters that if he had been, the trial would have been suspended.
Oxford stated the trial will continue after the death of the volunteer, adding an independent review had revealed no safety concerns.
‘Following careful assessment of this case in Brazil, there have been no concerns about safety of the clinical trial and the independent review in addition to the Brazilian regulator have recommended that the trial should continue,’ a spokesman for the university said in a statement.
In a statement to NBC News, AstraZeneca also confirmed the trial would go on.
‘We cannot comment on individual cases in an ongoing trial of the Oxford vaccine as we adhere strictly to medical confidentiality and clinical trial regulations, but we can confirm that all required review processes have been followed,’ the statement said.
‘All significant medical events are carefully assessed by trial investigators, an independent safety monitoring committee and the regulatory authorities. These assessments have not led to any concerns about continuation of the ongoing study.’
Reports say he was not part of the group that received the experimental jab and that he died from COVID-19 complications on October 15. Pictured: Brazilian pediatrician Dr Monica Levi, who received the COVID-19 vaccine, works at the Specialized Clinic in Infectious and Parasitic Diseases and Immunizations in Sao Paulo, Brazil, July 24
Oxford and Brazilian health authority Anvisa say testing will continue and that there are no safety concerns. Pictured: AstraZeneca’s offices in Macclesfield, Cheshire, England, July 21
Anvisa told FocusOn News that it learned of Feitosa’s death on October 19, an investigation was carried out by the International Safety Assessment Committee.
‘It is important to highlight that, based on the ethical confidentiality commitments provided for in the protocol, the regulatory agencies involved receive partial data related to the investigation carried out by this committee, which suggested that the study should continue, thus the process remains under evaluation.
‘Therefore, Anvisa reiterates that, according to national and international regulations of Good Clinical Practices, data on clinical research volunteers must be kept confidential, in accordance with principles of confidentiality, human dignity and protection of participants.’
The Federal University of Rio de Janeiro, of which Feitosa was an alum, released a statement expressing condolences on behalf of his girlfriend and friends.
‘João, I think that in this little text I could remember how good an exemplary doctor and student you were, but I think the memory that I will mention to everyone here will be different.
‘I want to keep the memory forever how good a boyfriend, brother and friend you were.
‘The pain in the chest, the emptiness and longing since you left are growing every moment and what gives us strength in that moment besides the affection of so many friends you made in life is remembering what you were like.’
Brazil has the second deadliest outbreak of coronavirus, with more than 154,000 killed by COVID-19, following only the United States.
It is the third worst outbreak in terms of cases, with more than 5.2 million infected, after the United States and India
Upon the news, AstraZeneca shares turned negative and were down 1.7 percent.
It comes as the US Food and Drug Administration (FDA) keeps the American arm of AstraZeneca’s trial on hold.
The late-stage study was paused on hold on September 8 when a British participant was rushed to the hospital after suffering a serious reaction.
An internal safety report revealed the patient was diagnosed with transverse myelitis, an inflammation of a section of the spinal cord.
The condition damages the myelin sheath, an insulating barrier of fatty protein that protects the nerves, and interrupts messages sent by spinal cord nerves.
This results in pain, weakness, abnormal sensations, and problems of the bladder and bowel – and can even lead to permanent paralysis.
Testing had resumed at all other sites, but not in America.
On Tuesday, it was revealed that the FDA had completed its review of safety data and was planning to let the trial resume in the US.
Allowing testing to resume likely means the FDA believes illness suffered by the British patient was not linked to the experimental vaccine.
However, the FDA is requiring researchers conducting the trial to add information about the incident to consent forms signed by study participants, a source told Reuters.
However, it is unclear if the death of the Brazilian patient will reverse this decision.